MAUDE Adverse Event Report: LOMBARD MEDICAL LTD. AORFIX AAA FLEXIBLE STENT GRAFT; ENDOVASCULAR STENT GRAFT

Model Number	SG-HBB-31-111-80-14
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	04/21/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A full review of the device history record for this device has been carried out with no anomalies identified; product was manufactured and released for sale in accordance with specifications.There is no information to suggest that the device has not met the final release criteria.The patient had a highly angulated, tortuous proximal neck and a neck length of approximately 40mm.
Event or Problem Description
Event: proximal side of main body fell down an aneurysm due to vessel flow.A main body was inserted from the left femoral artery by using a pull-through method.Following the ifu, the main body was initiated to be deployed a bit above the left lower renal artery.Then, it was positioned approximately 1 cm below the lower ra.The physician deployed the device to the contra-lateral socket.Right after releasing the support tube, he confirmed that the proximal side of the stent graft fell down the aneurysm due to the vessel flow.In order to address this situation, the physician first considered using a hpe or other competitor's proximal extender.However, he concluded that it is better to perform an open conversion surgery (to place a y-graft) rather than placing a proximal extender, anticipating at least more than 4 devices (including distal extenders and cuffs) will be required and even a high possibility of endoleaks.Open conversion surgery was successfully performed instead of the evar.The physician commented that the vessels were so extremely tortuous that the open conversion surgery was not avoidable as a result.

• Brand Name: AORFIX AAA FLEXIBLE STENT GRAFT
• Common Device Name: ENDOVASCULAR STENT GRAFT
• Manufacturer (Section D): LOMBARD MEDICAL LTD.; 4 trident park; didcot, oxfordshire OX11 7HJ; UK OX11 7HJ
• MDR Report Key: 5672483
• Report Number: 3004753364-2016-00015
• Device Sequence Number: 10765386
• Product Code: MIH
• UDI-Device Identifier: 05055715611541
• UDI-Public: (01)05055715611541(17)170114(10)CP58757-1
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P110032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/14/2017
• Device Model Number: SG-HBB-31-111-80-14
• Device Lot Number: CP58757-1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2016
• Initial Report FDA Received Date: 05/23/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 69 YR
• Patient Weight: 76